Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 6-470
Standard
USP-NF  M99660_03_01
<871> Sutures - Needle Attachment
Scope/Abstract
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
§878.4494 Suture, Recombinant Technology Class 2 NWJ
§878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Class 2 GAQ
§878.4495 Suture, Nonabsorbable, Nitinol Class 2 NJU
§878.4830 Suture, Absorbable, Natural Class 2 GAL
§878.4840 Suture, Surgical, Absorbable, Polydioxanone Class 2 NEW
§878.5000 Suture, Nonabsorbable, Synthetic, Polyester Class 2 GAS
§878.5000 Suture, Nonabsorbable, Synthetic, Polyethylene Class 2 GAT
§878.5010 Suture, Nonabsorbable, Synthetic, Polypropylene Class 2 GAW
§878.5010 Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) Class 2 MXW
§878.5020 Suture, Nonabsorbable, Synthetic, Polyamide Class 2 GAR
§878.5030 Suture, Nonabsorbable, Silk Class 2 GAP
§878.5035 Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Class 2 NBY
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff, issued June 2003.

Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology - Guidance for Industry and FDA Staff, issue August 2007.

DOI: https://doi.org/10.31003/USPNF_M99660_03_01.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Maegen Colehour
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6436
  maegen.colehour@fda.hhs.gov
Standards Development Organization
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
-
-